Position Summary
You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.
Key Responsibilities
- Serve as a clinical development expert for assigned studies; maintain current scientific/clinical knowledge in the therapeutic/disease area.
- Partner with clinical/medical colleagues, Clinical Operations, and cross-functional teams to implement and execute clinical trial(s).
- Provide scientific oversight and ensure data integrity and quality.
- Represent the study team in governance meetings and submissions; support study and disease area strategy with the Development lead/Medical Director.
- Author protocols and study-level informed consent documents; contribute to IBs, site training materials, clinical study reports, regulatory responses, and related documents.
- Set clinical data review strategy; lead quality data collection and review of emerging data/trends; review/query data and present to internal/external stakeholders.
- Partner with medically qualified colleagues to analyze emerging safety and keep clinical/safety teams informed.
- Follow SOPs/regulations and required trainings; improve quality/efficiency; lead or participate in workgroups optimizing clinical development procedures; act as subject matter expert/business process owner for a relevant SOP/procedure.
Minimum Qualifications
- PhD/PharmD (5+ years industry/CRO clinical research) OR MS (7+ years) OR BA/BS (10+ years).
- Phase 3/pivotal Oncology clinical research experience; ideally sponsor-side with successful regulatory submission/inspection/approval.
- Solid tumor or hematology trial experience.
- Experience leading a team.
- Expertise in clinical procedures, ICH, GCP; familiarity with FDA, EMA, and global regulations.
- Knowledge across Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance.
- Experience with large data sets; Microsoft Office and scientific software proficiency.
- Strong communication/presentation/organizational skills; experience using multiple communication tools.
- Collaborative problem-solving and constructive conflict handling.
- Scientific productivity (publications/posters/abstracts/presentations).
- Proactive, independent work organization and prioritization.
- Ability to build partnerships across the company to meet program needs.
Benefits (explicit)
- Annual base salary range: $176,600.00β$294,300.00; eligible for Global Performance Plan bonus (20% target) and share-based long-term incentive; comprehensive benefits including 401(k) with Pfizer matching, paid time off, caregiver/parental and medical leave, and health/dental/vision coverage.
Work Location
- Hybrid role; live within commuting distance; work on-site ~2.5 days/week.